Chronic Low Back PainEARSNCT03963440
Validation in French Language of the Questionnaire EARS
A study testing Exercise Adherence Rating Scale (EARS) in people with Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 5 sites in France.
Trial summary
The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain. Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exercise Adherence Rating Scale (EARS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Feb 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes
- Adult (>18 years old)
- Chronic Low Back Pain evolving for at least 3 months
- Acceptance to participate in the study
- Patients affiliated to a social security scheme (beneficiary entitled)
Who cannot join
- Patient under guardianship, or protection of justice.
- Patient in the incapacity to answer the questionnaire.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Lille
Lille, 59000
CHU de Montpellier
Montpellier, 34000
CHU de nîmes
Nîmes, 30000
Hôpital COCHIN
Paris, 75014
About this study
Official title: Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain
The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.
Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")
EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.
Read the detailed description
Self-management of the patient to perform these exercises involves good collaboration with the care prescriber, leaving patients to manage and monitor their health. Long-term adherence to care programs, including physical exercise, is paramount for these patients in order to maintain a beneficial long-term effect, which is the case in non-specific chronic low back pain. However, evidence shows that compliance levels following a physical exercise prescription are low, limiting the benefits this could bring.
Currently, EARS is validated for chronic low back pain in its English version. To our knowledge and to the knowledge of the questionnaire's author, E.Godfrey, there are no other studies that have examined the validation of EARS in the French language for chronic low back pain.
Patients will be asked to complete a series of questionnaires after completing the non-opposition form. The management of non-specific chronic low back pain also requires evaluation through questionnaires, in accordance with the usual practices of the services participating in the study. No intervention will be taken.
- Conditions
- Chronic Low Back Pain
- Being tested
- Exercise Adherence Rating Scale (EARS)
- Keywords
- Chronic low back pain, Physical activity, Questionnaire, Adhesion
- Medical subject headings
- Motor Activity, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Adherence Rating Scale (EARS)Other
Also called Quebec Back Pain Disability Scale, International Physical Activity Scale (IPAQ), Hospital Anxiety and Depression (HAD), Evaluation du fardeau lié à la réalisation des exercices physiques (ETBQ)
Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care).
Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care.
Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments.
| Study group | Role | What they receive |
|---|---|---|
| Cohorte 1 | Experimental | Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care).
Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care.
Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments. Receives: Other: Exercise Adherence Rating Scale (EARS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of the French questionnaire EARS
(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)
Measured: 0 day, 2 days, 15 days, 3 months
Secondary outcomes (9)
The fears and the faiths measured by questionnaire FABQ
The FABQ can help predict those that have a high pain avoidance behavior. Clinically, these people may need to be supervised more than those that confront their pain.
The FABQ contains 2 scales: a work scale (FABQ-W) composed of 7 items and a physical activity scale (FABQ-PA) composed of 4 items. The two scales are scored separately. Higher FABQ scores indicate elevated fear-avoidance beliefs.
"FABQ-W" has a point score that ranges from 0-42 points. It can be calculated as follows: (Total points for items 6, 7, 9, 10 11, 12 and 15) = Work scale score.
"FABQ-PA" can range from 0-24 points. Scores are calculated as follows: (Total points for items 2, 3, 4 and 5) = Physical activity scale score.
Measured: at day 0, 15 days, 3 months
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
The questionnaire consists of 14 items and each item is scored on a 5-point Likert agreement scale (ranging from strongly agree to strongly disagree). Only nine items are used in the scoring of the questionnaire with the remaining items considered 'distracters' from which no scores are derived. Possible scores range between 9 and 45, with lower scores indicating more maladaptive or pessimistic beliefs about back pain.
Measured: at day 0, 15 days, 3 months
The knowledge of emotional state measured by questionnaire HAD
The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.
One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Scoring :
0-7- normal, 8-10-borderling abnormal, 11-21-abnormal
Measured: at day 0, 15 days, 3 months
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
This questionnaire is about the way your back pain is affecting your daily life. People with back problems may find it difficult to perform some of their daily activities. For each activity there is a scale of 0 to 5 :0 - " not difficult at all " , 1 - " minimally difficult " , 2 - " somewhat difficult " , 3 - " fairly difficult " , 4 - " very difficult " and 5 - " unable to do ". Minimum detectable change (90% confidence) 15 points.
Measured: at day 0, 15 days, 3 months
Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ
(Exercise Therapy Burden Questionnaire), consisting of 10 items. For each activity there is a scale of 0 to 10 : 0 - not agree at all, 10 - completely agree. Some items of the ETBQ belong to side effects and others to the workload of health care. (lower score=better)
Measured: at day 0, 15 days, 3 months
The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).
Measured: at day 0, 15 days, 3 months
The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items)
10-item RTWSE scale with the goal of assessing self-efficacy of workers to return to work within two conceptual domains: controlling pain at work and obtaining help. For each question there is a scale of to 5: 1 - not sure at all, 5 - really sure. Higher score = better self-efficiency.
Measured: at day 0, 15 days, 3 months
Level of physical activity measured by short questionnaire IPAQ
Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level Scoring a MODERATE level of physical activity on the IPAQ means some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.
Scoring a LOW level of physical activity on the IPAQ means any of the criteria for either MODERATE of HIGH levels of physical activity.
Measured: at day 0, 15 days, 3 months
Patient Global Impression of Change by Scale PGIC
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item.
Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.
Measured: 15 days, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cross-cultural validation study of a questionnaire, interventional research involving the human person chronic low back pain, prospective, with cross-sectional cohort follow-up, multi-centric
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, MD-PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963440
- Sponsor's protocol ID
- RNI 2018 COUDEYRE
- Other IDs
- 2018-A00616-49
- Acronym
- EARS
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.
PubMed 2961080Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and intervention-related factors associated with adherence to home exercise in chronic low back pain: a systematic review. Spine J. 2013 Dec;13(12):1940-50. doi: 10.1016/j.spinee.2013.08.027. Epub 2013 Oct 26.
PubMed 24169445Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
PubMed 25511175Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Hall AM, Kamper SJ, Hernon M, Hughes K, Kelly G, Lonsdale C, Hurley DA, Ostelo R. Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):552-62. doi: 10.1016/j.apmr.2014.07.405. Epub 2014 Aug 6.
PubMed 25108098
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03963440
- Acronym / sponsor ID
- EARS / RNI 2018 COUDEYRE
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Physical activity, Questionnaire, Adhesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.
Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")
EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.
Detailed description
Self-management of the patient to perform these exercises involves good collaboration with the care prescriber, leaving patients to manage and monitor their health. Long-term adherence to care programs, including physical exercise, is paramount for these patients in order to maintain a beneficial long-term effect, which is the case in non-specific chronic low back pain. However, evidence shows that compliance levels following a physical exercise prescription are low, limiting the benefits this could bring.
Currently, EARS is validated for chronic low back pain in its English version. To our knowledge and to the knowledge of the questionnaire's author, E.Godfrey, there are no other studies that have examined the validation of EARS in the French language for chronic low back pain.
Patients will be asked to complete a series of questionnaires after completing the non-opposition form. The management of non-specific chronic low back pain also requires evaluation through questionnaires, in accordance with the usual practices of the services participating in the study. No intervention will be taken.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-cultural validation study of a questionnaire, interventional research involving the human person chronic low back pain, prospective, with cross-sectional cohort follow-up, multi-centric
| Arm | Type | Receives |
|---|---|---|
| Cohorte 1 | Experimental | Other: Exercise Adherence Rating Scale (EARS)Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care). Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care. Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both sexes
- Adult (>18 years old)
- Chronic Low Back Pain evolving for at least 3 months
- Acceptance to participate in the study
- Patients affiliated to a social security scheme (beneficiary entitled)
Key exclusion criteria (2 listed)
- Patient under guardianship, or protection of justice.
- Patient in the incapacity to answer the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Adherence Rating Scale (EARS)Also: Quebec Back Pain Disability Scale, International Physical Activity Scale (IPAQ), Hospital Anxiety and Depression (HAD), Evaluation du fardeau lié à la réalisation des exercices physiques (ETBQ)Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care). Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care. Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments. | Other | Cohorte 1 |
Primary outcome
Psychometric properties of the French questionnaire EARS
Time frame: 0 day, 2 days, 15 days, 3 months
(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)
9 secondary outcomes
The fears and the faiths measured by questionnaire FABQ
Time frame: at day 0, 15 days, 3 months
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Time frame: at day 0, 15 days, 3 months
The knowledge of emotional state measured by questionnaire HAD
Time frame: at day 0, 15 days, 3 months
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Time frame: at day 0, 15 days, 3 months
Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ
Time frame: at day 0, 15 days, 3 months
The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
Time frame: at day 0, 15 days, 3 months
The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items)
Time frame: at day 0, 15 days, 3 months
Level of physical activity measured by short questionnaire IPAQ
Time frame: at day 0, 15 days, 3 months
Patient Global Impression of Change by Scale PGIC
Time frame: 15 days, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 2961080Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.
- Background: PubMed 24169445Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and intervention-related factors associated with adherence to home exercise in chronic low back pain: a systematic review. Spine J. 2013 Dec;13(12):1940-50. doi: 10.1016/j.spinee.2013.08.027. Epub 2013 Oct 26.
- Background: PubMed 25511175Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background: PubMed 25108098Hall AM, Kamper SJ, Hernon M, Hughes K, Kelly G, Lonsdale C, Hurley DA, Ostelo R. Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):552-62. doi: 10.1016/j.apmr.2014.07.405. Epub 2014 Aug 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COUDEYRE, MD-PhD principal investigator
University Hospital, Clermont-Ferrand
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Adherence Rating Scale (EARS) in people with Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric properties of the French questionnaire EARS (time frame: 0 day, 2 days, 15 days, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963440, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.